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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K254162
Device Name KLS Martin Ixos System
Applicant
KLS Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Applicant Contact Melissa Bachorski
Correspondent
KLS Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Correspondent Contact Liza Gordillo
Date Received12/22/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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